J-Code for ThromboGenics' JETREA to Become Effective January 1, 2014
LEUVEN, Belgium, December 3, 2013 /PRNewswire/ --
Permanent J-Code J7316 will lead to streamlined reimbursement of JETREA® in the US
ThromboGenics NV (Euronext Brussels: THR), an integrated biopharmaceutical company focused on developing and commercializing innovative ophthalmic medicines, announces that CMS (Center for Medicare and Medicaid Services) has published the permanent HCPCS (Healthcare Common Procedure Coding System) code for JETREA (ocriplasmin) J7316. The permanent J-Code for JETREA® will become effective 1 January 2014.
The absence of a HCPCS code for JETREA® has meant that US physicians have had to manually submit JETREA claims to payers following their use of this novel treatment for symptomatic VMA (vitreomacular adhesion). This has led to delays in reimbursement, and certain inefficiencies in use of financial working capital at a retina practice management level. The permanent J-Code will streamline the reimbursement process for retina practices and instil higher reimbursement confidence. Recent market research conducted by ThromboGenics has highlighted that the lack of a permanent J-Code is having an adverse impact on the uptake of JETREA®.
Dr Patrik De Haes, CEO of ThromboGenics said, "We are extremely pleased that the CMS has granted a permanent J-Code for JETREA®. We are confident that the automation of the reimbursement process will be an important facilitator in this novel product's uptake as US physicians will now be reimbursed for JETREA® in a timelier and more efficient manner."
About JETREA® (ocriplasmin)
JETREA® (ocriplasmin) is a truncated form of human plasmin. In the US, JETREA® is indicated for the treatment of symptomatic VMA. In Europe, JETREA® is indicated for the treatment of vitreomacular traction (VMT), including when associated with macular hole of diameter ≤ 400 microns. JETREA® is a selective proteolytic enzyme that cleaves fibronectin, laminin and collagen, three major components of the vitreoretinal interface that play an important role in vitreomacular adhesion.
JETREA® has been evaluated in two multi-center, randomized, double-masked Phase III trials conducted in the U.S. and Europe involving 652 patients with vitreomacular adhesion. Both studies met the primary endpoint of resolution of VMA at day 28.
JETREA's Phase III program found that 26.5% of patients treated with ocriplasmin saw resolution of VMA, compared with 10.1% of patients receiving placebo (p<0.01). The Phase III program also showed that JETREA was generally well tolerated with most adverse events being transient and mild in severity.
ThromboGenics is an integrated biopharmaceutical company focused on developing and commercializing innovative ophthalmic and oncology medicines. The Company's lead product, JETREA® (ocriplasmin), has been approved by the US FDA for the treatment of symptomatic VMA and was launched in January 2013.
ThromboGenics signed a strategic partnership with Alcon (Novartis) for the commercialization of JETREA® outside the United States. Under this agreement, ThromboGenics could receive up to a total of €375 million in up-front and milestone payments. It will receive significant royalties from Alcon's net sales of JETREA®. ThromboGenics and Alcon intend to share the costs equally of developing JETREA® for a number of new vitreoretinal indications.
In Europe, JETREA® is approved for the treatment of vitreomacular traction (VMT), including when associated with macular hole of diameter less than or equal to 400 microns. Alcon has launched JETREA® in the UK, Germany, Finland, Denmark, Norway and Sweden. It has also recently introduced this novel product in Canada.
ThromboGenics is also further exploring anti-PIGF (Placental Growth Factor), also referred to as TB-403, for the treatment of ophthalmic and oncology indications.
ThromboGenics is headquartered in Leuven, Belgium, and has-offices in Iselin, NJ (US) and Dublin, Ireland. The Company is listed on the NYSE Euronext Brussels exchange under the symbol THR. More information is available at http://www.thrombogenics.com.
Important information about forward-looking statements
Certain statements in this press release may be considered "forward-looking". Such forward-looking statements are based on current expectations, and, accordingly, entail and are influenced by various risks and uncertainties. The Company therefore cannot provide any assurance that such forward-looking statements will materialize and does not assume an obligation to update or revise any forward-looking statement, whether as a result of new information, future events or any other reason. Additional information concerning risks and uncertainties affecting the business and other factors that could cause actual results to differ materially from any forward-looking statement is contained in the Company's Annual Report.
This press release does not constitute an offer or invitation for the sale or purchase of securities or assets of ThromboGenics in any jurisdiction. No securities of ThromboGenics may be offered or sold within the United States without registration under the U.S. Securities Act of 1933, as amended, or in compliance with an exemption therefrom, and in accordance with any applicable U.S. state securities laws.
For further information please contact:
Wouter Piepers, Global Head of Corporate Communications
+32-16-75-13-10 / +32-478-33-56-32
Dr. Patrik De Haes, CEO
Chris Buyse, CFO
Citigate Dewe Rogerson
David Dible/ Sita Shah
The Trout Group (US investor relations)
Todd James/ Simon Harnest